Heart Disease Clinical Trial
Official title:
A Randomised Controlled Trial on the Efficacy of High Intensity Interval Training Compared With Moderate Intensity Interval Training for Patients Undergoing Cardiac Rehabilitation
Cardiac rehabilitation is a program designed to help patients regain good health through
lifestyle change after a heart attack, heart surgery or other heart problems. Patients will
take part in exercise sessions and education lessons, tailored to meet their personal needs.
The exercise training component of cardiac rehabilitation may be delivered as intervals of
short intense sessions (also known as high intensity intervals) or the current standard care
of longer but less intense sessions (moderate intense intervals). Both exercises have been
shown to increase fitness levels and also prevent future risk of heart disease.
The purpose of this study is to determine the efficacy and safety of high intensity interval
exercise training (HIIT) in patients who had a recent cardiac revascularization procedure or
recovering from a heart attack, in comparison to current standard of moderate intensity
exercise training in terms of their physical fitness and psychological well-being.
Status | Completed |
Enrollment | 34 |
Est. completion date | June 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - History of acute coronary syndromes, had a recent revascularization procedure - History of stable heart failure or stable angina. Exclusion Criteria: - Unstable angina - Systolic blood pressure of >200 mm Hg, or diastolic blood pressure >110 mm Hg (should be assessed on a case-by-case basis) - Orthostatic blood pressure drop of >20 mm Hg with symptoms - May have had the implantation of cardiac defibrillators (ICD) - Synchronization devices or ventricular assist devices - Have had a heart valve repair/replacement, a heart transplant, or grown-up congenital heart disease, critical aortic stenosis, acute systemic illness or fever, - - Uncontrolled atrial or ventricular arrhythmias, acute pericarditis or myocarditis - Recent embolism, thrombophlebitis, resting S-T segment depression (>2 mm), uncontrolled diabetes (should be assessed in accordance with local protocol and on a case-by-case basis) - Severe orthopedic conditions that would prohibit exercise - Other metabolic conditions, such as acute thyroiditis, hypokalemia or hyperkalemia, hypovolemia, severe rejection (cardiac transplant recipients), triple A >4.5 cm (if under surveillance will need confirmation from vascular surgeon as long as blood pressure remains stable) - Tachycardia >100 beats per minute at rest, or cataracts (may commence exercise after 6 weeks) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United Kingdom | Liverpool Heart and Chest Hospital | Liverpool |
Lead Sponsor | Collaborator |
---|---|
Liverpool Heart and Chest Hospital NHS Foundation Trust | Edge Hill University |
United Kingdom,
Currie KD, Rosen LM, Millar PJ, McKelvie RS, MacDonald MJ. Heart rate recovery and heart rate variability are unchanged in patients with coronary artery disease following 12 weeks of high-intensity interval and moderate-intensity endurance exercise traini — View Citation
Fletcher GF, Balady GJ, Amsterdam EA, Chaitman B, Eckel R, Fleg J, Froelicher VF, Leon AS, Piña IL, Rodney R, Simons-Morton DA, Williams MA, Bazzarre T. Exercise standards for testing and training: a statement for healthcare professionals from the America — View Citation
Guiraud T, Nigam A, Gremeaux V, Meyer P, Juneau M, Bosquet L. High-intensity interval training in cardiac rehabilitation. Sports Med. 2012 Jul 1;42(7):587-605. doi: 10.2165/11631910-000000000-00000. Review. — View Citation
Munk PS, Butt N, Larsen AI. High-intensity interval exercise training improves heart rate variability in patients following percutaneous coronary intervention for angina pectoris. Int J Cardiol. 2010 Nov 19;145(2):312-4. doi: 10.1016/j.ijcard.2009.11.015. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Changes in reported incidents of acute pain (as measured by a visual analogue scale) | Pain is a contributing factor to the displeasure experienced during some exercise (Ekkekakis et al. 2012). For this reason participants will be required to complete a visual analogue scale to quantify any pain during the sessions. Changes in perception of pain will assessed between baseline and 8 weeks after the start of intervention. | Changes between baseline incidents of acute pain and 8 weeks after start of intervention | Yes |
Primary | Changes in Heart Rate Variability (as measured by a hemodynamic monitoring system) | The primary outcome is the difference in heart rate variability between baseline and 8 weeks after the start of the intervention measured using finger photoplethysmography | Change from baseline in heart rate variability at 8 weeks after the start of the intervention | No |
Secondary | Changes in Baroreflex Sensitivity (as measured by a hemodynamic monitoring system) | This is the difference in heart rate variability between baseline and 8 weeks after the start of intervention measured using finger photoplethysmography | Change from baseline in baroreflex sensitivity at 8 weeks after the start of the intervention | No |
Secondary | Changes in Peak Oxygen Uptake (as measured by a submaximal exercise test) | Submaximal Cardiopulmonary Exercise Testing will be performed to measure changes in peak oxygen uptake between baseline and 8 weeks after the start of the intervention | Changes in peak oxygen uptake between baseline and 8 weeks after the start of intervention | Yes |
Secondary | Changes in Enjoyment of Exercise (as measured by a questionnaire) | Changes in pleasure and displeasure, affect, arousal between baseline and 8 weeks after the start of intervention will be assessed by using a "Feelings Scale", "Felt Arousal Scale", "Physical Activity Enjoyment Scale" respectively. | Changes in perception of enjoyment of exercise at between baseline and 8 weeks after the start of intervention | No |
Secondary | Changes in health-related Quality of Life (as measured by a questionnaire) | Changes in health-related quality of life between baseline and 8 weeks after the start of intervention will be measured by completion of MacNew Quality of Life questionnaires | Changes in health-related quality of life between baseline and 8 weeks after the start of intervention | No |
Secondary | Changes in Rating of Perceived Exertion (as measured by a scale) | Ratings of perceived exertion (RPE) allow the intensity of exercise to be determined subjectively on a scale of 6-20. Changes in RPE scales will be assessed at start of each workout as part of service protocol to gauge patient effort, fatigue and muscular discomfort and the differences between baseline and 8 weeks after start of intervention will be determined. At the end of each session, patients will be expected to submit an overall session RPE of how they perceived the entire exercise session (Kilpatrick et al. 2014). | Changes in the rating of perceived exertion between baseline and 8 weeks after start of intervention | No |
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